Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices had already attained about 80% market penetration, a testimony to the essential function in verifying drug authenticity, patient safety, and end-to-end supply chain transparency.

Pharmaceutical serialization explained

Serialization in the drug sector is the process of affixing a unique code to every individual unit of a package—be it a blister pack, bottle, carton, or other type of primary and secondary packaging configuration. A serialized drug product usually includes crucial details such as product identification numbers, unique serial numbers, lot numbers, and expiry dates. Serialization gives all stakeholders across the pharmaceutical supply chain—from the manufacturers to the distributors and dispensers—the tools they need to track every unit accurately by checking authenticity and integrity at every juncture of the product life cycle.

Given recent regulatory developments, it’s essential for businesses to have a clear picture of serialization requirements, because the complexity and ongoing evolution of serialization regulation across various global markets have introduced significant operational challenges for pharmaceutical companies. Therefore, manufacturers and distributors must remain proactively informed and regularly update their operational practices to guarantee compliance, prevent costly enforcement actions, and ultimately protect patient safety and brand reputation.

Serialization requirements in the US market and the DSCSA

The Drug Supply Chain Security Act (DSCSA), which was implemented in 2013 to establish rigorous standards for tracing and verifying pharmaceutical products in the United States, officially concluded its stabilization period on Nov. 27, 2024. It should be noted that this pivotal milestone has triggered a phased removal of previously granted regulatory exemptions, significantly affecting manufacturers, repackagers, wholesale distributors, and dispensers that employ 26 or more full-time staff members. As these exemptions gradually expire, revisiting DSCSA serialization requirements is essential to ensure seamless operational continuity and robust regulatory adherence in this fast-evolving compliance landscape.

DSCSA serialization requirements: A brief overview

According to Section 582(a)(9) of the Food, Drug, and Cosmetic Act (FD&C Act), each pharmaceutical package must bear a standardized numerical identifier that includes several critical data elements:
• The National Drug Code (NDC)—often encoded within a GTIN-14
• An alphanumeric serial number including up to 20 characters
• The product’s lot number
• The expiration date

These identifiers should be prominently shown in human-readable form for immediate visual checking, as well as encoded in machine-readable, 2D data-matrix barcodes for streamlined automation handling.

To add one more layer of detail, individual units of products are required to employ a data matrix barcode, while homogeneous cases—e.g., packages comprising the same units of the drug product with the same lot numbers and date of expiration—can display either linear barcodes or the 2D type of barcode.

In any case, it should be highlighted that compliance with such specifications enhances traceability all along the supply chain, drastically minimizing risks due to counterfeit drugs.

Serialization requirements abroad: The EU’s Falsified Medicine Directive

As any pharmaceutical exporter well knows, Europe is one of the largest markets in the world. Its market size is expected to grow from about $488 billion in 2024 to $688 billion by 2030, as highlighted in Grand View Research’s estimations. Given such a large market presence and potential business prospects, an in-depth knowledge of the European Falsified Medicines Directive (FMD) and the requirements set by the EU’s regulation is important, enabling manufacturers and exporters to operate effortlessly and efficiently throughout the continent.

Serialization requirements for the EU

As per European Delegated Regulation (EU) 2016/161—which incorporates the basic 2011 FMD guidelines—drug packaging should have basic safety features in the form of a unique identifier (UI) and a distinctive antitampering device (ATD).

As for the graphical user interface (GUI), it can be characterized as an essential set of information that consists of:
• The product code (typically incorporated in a GTIN-14)
• A randomly allocated numeric or alphanumeric code of a maximum of 20 characters to reduce duplication or forgery risks
• A lot/batch number
• An expiration date
• A national reimbursement code, if applicable (e.g., the Italian AIC, in the national drug authorization code made available by the national medicine agency)

Note that European regulations require these identifiers to be encoded in a GS1 data matrix barcode, accompanied by clearly visible and human-readable text.

The antitampering device required by the FMD is defined as a physical, tamper-evident seal to visibly demonstrate any illicit effort to access the package or modify it. Unlike the DSCSA, the FMD treats the antitamper device as a mandatory feature, considering it a key security measure to safeguard against unauthorized access.

How to identify the right solutions for serialization regulations compliance

Serialization compliance requires having the right solution for the specific type of product and packaging used. To implement effectively, it’s critical to differentiate between marking and labeling technologies.

For serialization practices, marking technologies’ specific functions consist of physically imprinting the serialization information onto the primary packaging, like blister packs, bottles, and flexible-film packaging materials. For example, laser marking and thermal transfer overprinting (TTO) are common examples of this type of solution, offering reliability, accuracy, and resilience in severe environmental elements.

On the other hand, labeling technologies deploy print-and-apply systems to create and affix serialized labels to secondary packaging and carton boxes. These systems are generally fully capable of managing specific operations, such as affixing tamper-evident seals, to provide an additional layer of security against improper opening by unauthorized agents.

Marking technologies for primary packaging

Within the drug sector, using laser-marking technology for marking primary packaging configurations such as vials, bottles, and blister packs is quite common. Lasers can mark products with permanent high-quality identifiers on the surfaces of packaging materials. Thermal transfer overprinters (TTO) are ideal for use with semirigid film packaging, including stick packs. TTO systems use thermal ribbons to impress ink on the surface of the packaging material, resulting in precisely positioned and high-resolution barcodes and text.

Print-and-apply systems for secondary packaging

As the name clearly suggests, print-and-apply labeling technologies are generally ideal for secondary packaging because they can directly print and apply serialized labels on folding cartons with extremely high precision, even in high-speed production lines.

Another relevant option provided by print-and-apply systems is the application of tamper-evident labels, like VOID, which are essential features in the context of the EU’s FMD security specifications and compliance requirements.

Summary

Serialization compliance entails managing intricate regulatory requirements and choosing appropriate technologies based on the specific needs of each pharmaceutical market. That’s why working with experienced partners that help businesses navigate the complexities behind choosing the right solution makes a big difference.

With long-held expertise and vast experience in marking and labeling for the industrial sector, Nimax services include accurate consulting activities and innovative technology solutions ready for seamless integration in pharmaceutical production lines.